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Hepatitis C, Chronic clinical trials

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NCT ID: NCT04201275 Completed - Chronic Hepatitis C Clinical Trials

The Tolerability, Pharmacokinetics and Pharmacodynamics Study of HEC74647 in HCV-infected Subjects

Start date: December 18, 2019
Phase: Phase 1
Study type: Interventional

The goal of this study is to assess the tolerability, pharmacokinetics and antiviral activity of HEC74647 in HCV treatment naïve subjects with genotypes 1-6.

NCT ID: NCT04198584 Completed - Chronic Hepatitis C Clinical Trials

Study of Telemedicine Stress Management and Lifestyle Group Intervention for HCV Patients

VC-CBCS
Start date: April 10, 2020
Phase: N/A
Study type: Interventional

A pilot feasibility study of a small randomized controlled trial (RCT) comparing a video-conferencing cognitive behavioral coping skills (VC-CBCS) group to standard of care (SC) for symptomatic patients previously diagnosed with chronic hepatitis C to evaluate feasibility, patient satisfaction and differences in symptoms, quality of life and liver markers.

NCT ID: NCT04189627 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of the Effectiveness and Clinical Practice Use of Glecaprevir/Pibrentasvir in Adolescents With Chronic Hepatitis C Genotypes 1 to 6 in Russian Federation

DETI-2
Start date: February 17, 2020
Phase:
Study type: Observational

The objective of this study is to assess the effectiveness of the glecaprevir/pibrentasvir (GLE/PIB) regimen in adolescent participants aged 12 to <18 years of age with chronic hepatitis C (CHC) in clinical practice in the Russian Federation. The study also plans to assess effectiveness of GLE/PIB in subpopulations of interest like co-infected hepatitis C virus (HCV)/human immunodeficiency virus (HIV) adolescents, in various HCV genotype/subgenotype, cirrhotic and non-cirrhotic participants, treatment-experienced (prior treatment with pegylated interferon (pegIFN) or IFN, and/or Ribavirin (RBV) and/or sofosbuvir [PRS]) and treatment-naïve, adolescents who use drugs (PWUD) and non-drug users.

NCT ID: NCT04177043 Completed - Clinical trials for Hepatitis C, Chronic

Model Towards Elimination of Hepatitis C Infection in Egypt: Feasibility and Effectiveness in 73 Villages

Start date: June 2015
Phase: Phase 4
Study type: Interventional

Background: The global response to the HCV infection epidemic has been transformed by the availability of low-cost curative short course direct acting antiviral (DAA) therapy. Egypt has one of the highest burdens of HCV infection worldwide, and a large treatment programme, but reaching rural communities represents a major challenge. We report the feasibility and effectiveness of a comprehensive community-based HCV prevention, testing and treatment model in 73 villages across Egypt, with the goal to eliminate infection from all adult villagers. Methods: An HCV "educate, test and treat" programme was implemented in 73 villages across 7 governorates in Egypt between 06/2015 and 06/2018. The programme model comprised community mobilization facilitated by a network of village promoters to support the education, test and treat campaign as well as fund raising in the local community; a comprehensive testing, linkage to care and treatment of all eligible villagers aged 12 to 80 years using HCV antibody and HBsAg rapid diagnostic tests (RDTs), HCV RNA confirmation of positive cases, staging of liver disease using transient elastography (FibroScan), treatment with 12 or 24 weeks of a direct acting antiviral (DAA) regimen according to national standard of HCV care, and an assessment of cure at 12 weeks after completion of treatment (SVR12); and an education campaign to raise awareness and disseminate messages about safer practices to reduce transmission through public events, promotional materials and house-to-house visits. Key outcomes assessed in each village were: uptake of serological HCV and HBV testing, linkage to assessment and HCV viral load confirmation, uptake of treatment, and SVR12.

NCT ID: NCT04136405 Active, not recruiting - Chronic Hepatitis c Clinical Trials

Cross Sectional Survey on the Burden, Impacts and Causes of Hepatitis C Virus (HCV) Outbreak in South West Region in Burkina Faso

REVERSO
Start date: July 14, 2020
Phase:
Study type: Observational

This study investigates hepatitis C virus (HCV) outbreak in South West general population in Burkina Faso with three specific objectives: estimate HCV prevalence in South West Region general population in 2019; identify factors associated with recent HCV infection (in subjects younger than 20 years); and evaluate the pilot treatment strategy implemented by the national program for diagnosed cases during investigation.

NCT ID: NCT04094272 Completed - Chronic Hepatitis c Clinical Trials

Pulmonary Arterial Hypertension in Patients With Direct-Acting Antiviral Medications for Hepatitis C Virus Infection

Start date: July 1, 2017
Phase:
Study type: Observational

The purpose of this study is the evaluation of PAH in patients, who are treated with DAA medication for HCV infection.

NCT ID: NCT04071353 Recruiting - Chronic Hepatitis C Clinical Trials

Observational Cohort Study of Clinical Outcomes After Antiviral Therapy for Chronic Hepatitis C

Start date: August 1, 2019
Phase:
Study type: Observational

This study was a clinical observational cohort study of two-way, non-intervention long-term dynamic follow-up. Enrolled in the Department of Liver Diseases, Beijing Ditan Hospital, Capital Medical University, with interferon combined with ribavirin (PR) antiviral therapy (PR treatment greater than or equal to 6 months) and/or direct acting antivirals (DAAs) In patients with chronic hepatitis C, the baseline, antiviral treatment and withdrawal follow-up data before the antiviral treatment were collected, and the patients were followed up for 3-6 months. Clinical data such as clinical biochemistry, HCV RNA and serological markers (anti-HCV), AFP and liver imaging (liver ultrasound) were collected during the study period. At least 144 weeks of observation on the virological response and clinical outcome of anti-viral treatment of chronic hepatitis C, the main evaluation index of liver cancer and decompensated liver cirrhosis after stopping the drug, and exploring the antiviral treatment of patients Long-term virological response and clinical outcomes, clarifying their influencing factors.

NCT ID: NCT04070235 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

SH229 Tablets Combined With Daclatasvir Dihydrochloride Tablets in Treatment Adult Patients With Chronic Hepatitis C

Start date: March 29, 2019
Phase: Phase 2/Phase 3
Study type: Interventional

Phase II: Exploring the efficacy and safety of different doses of SH229 tablets combined with fixed-dose Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a basis for the design and implementation of phase III clinical trials. Phase III: Confirmation of the efficacy and safety of SH229 tablets combined with Daclatasvi dihydrochloride (DCV) tablets in the treatment of adult patients with chronic hepatitis C for 12 weeks, providing a sufficient basis for drug registration and clinical use.

NCT ID: NCT04061551 Recruiting - Hepatitis C Clinical Trials

Eliminate Hepatitis C/EC Partnership Evaluation Protocol

Start date: December 2016
Phase: N/A
Study type: Interventional

The Eliminate Hepatitis C (EC) Partnership project is a multi-site, multi-year project aiming to enhance and extend hepatitis C virus (HCV) care and treatment among people who inject drugs (PWID) through nurse-led models of care in the community and the prison system. The project will implement and evaluate a health service intervention to enhance HCV response by improving health promotion, offering training and education to service providers, streamlining clinical pathways, utilising data systems and surveillance and implementing the results of ongoing research and evaluation. Health services data will be used to assess the impact of the EC nurse-led support, to enhance the clinical pathway and increase HCV testing, linkage to care and treatment uptake in community and prison settings. This will include provider and client interviews and a sentinel surveillance system (ACCESS) that will track and monitor impact indicators including HCV testing, linkage to care and treatment uptake at the service and population level. Overall, evaluation data will be used to monitor the uptake of HCV treatment in PWID, monitor the effectiveness of community- and prison-based treatment program and assess the cost and feasibility of treating >1160 PWID in community-/prison-based program and assess changes in HCV prevalence in Victoria and modelling the impact of treating PWID to inform HCV elimination models in Australia and globally.

NCT ID: NCT04039698 Active, not recruiting - Chronic Hepatitis C Clinical Trials

Monitoring of Hepatitis C Treatment Using Telemedicine - a Clinical Trial in Public Health System in Brazil

Start date: August 23, 2019
Phase: N/A
Study type: Interventional

The study is a non-randomized, single group clinical trial on monitoring hepatitis C therapy using telemedicine. Patients with chronic hepatitis C without cirrhosis will be treated with the pangenotypic regimen of direct acting antivirals sofosbuvir and velpatasvir for 12 weeks after a single visit to the clinic, in which treatment will be prescribed. Patients will be then monitored by telemedicine tools, like instant message application, telephone and video calls and by his or her primary physician when needed. Twelve weeks after treatment conclusion, hepatitis C virus RNA levels will be measured on a blood sample, indicating the cure rate and efficacy of this protocol on HCV treatment. The primary objective of the study is to address the feasibility and applicability of the usage of telemedicine tools to increase access and monitor HCV treatment with direct-acting antivirals in public health in Brazil.